Treatment for recurrent or metastatic vulvar cancer using AK104
A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer
This study is testing a new treatment called AK104 to see if it can help people with recurrent or metastatic vulvar cancer that can't be treated with surgery or radiation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Akeso Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Fuzhou, Fujian and 5 other locations) |
| Trial ID | NCT05932212 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, phase II clinical study evaluates the efficacy and safety of AK104, a bispecific antibody targeting PD-1 and CTLA-4, in patients with recurrent or metastatic vulvar cancer that cannot be treated with surgery or radiotherapy. Participants may receive AK104 alone or in combination with chemotherapy agents such as Paclitaxel and either Cisplatin or Carboplatin. The study aims to determine how well this treatment works in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 80 with histologically confirmed recurrent or metastatic vulvar cancer who have not responded to previous systemic therapies.
Not a fit: Patients with other types of vulvar cancer or those who have received prior immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced vulvar cancer who have limited treatment choices.
How similar studies have performed: Other studies using similar immune checkpoint inhibitors have shown promising results, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age \>=18 and \<=80. ECOG of 0 or 2. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy. For Cohort A, subjects should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy. At least one measurable tumor lesion per RECIST v1.1. Adequate organ function as assessed in the laboratory tests. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception Exclusion Criteria: Subjects with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc. Systemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration. Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.). Active or potentially recurrent autoimmune disease.
Where this trial is running
Fuzhou, Fujian and 5 other locations
- Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
- Sun Yant-Sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
- The Fourth Hospital of Hebei Medical University — Shijiangzhuang, Hebei, China (Not_yet_recruiting)
- Liaoning Cancer Hospital & Insitut — Shenyang, Liaoning, China (Recruiting)
- Tianjin medical university Cancer Institut & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Ting Liu, MD
- Email: clinicaltrials@akesobio.com
- Phone: +86(0760)89873999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.